Class 1 Recall

Automatic external defibrillators are intended to be used for the treatment of cardiac arrest. The defibrillators deliver a shock to the heart to restore normal heart rhythm. Prior to delivering the shock, the device analyzes the patient’s heart rhythm to determine if a shock is appropriate.

Recalling Firm:

Defibtech®, LLC
741 Boston Post Road, Suite 201
Guilford, CT 06437

Reason for Recall:

Defibtech®, LLC, is initiating a voluntary worldwide recall of Lifeline® Semi-automatic External Defibrillators (AEDs) and ReviveR® Semi-automatic External Defibrillators (AEDs). This recall affects all Lifeline® and ReviveR® AEDs with software versions 2.002 and earlier. The self-test software for these devices may allow a self-test to clear a previously detected low battery condition. If this situation occurs, the operator may be unaware of the low battery, and the device may be unable to deliver a defibrillation shock, which could result in failure to resuscitate a patient.

Public Contact:

Consumers with questions may contact the Customer Service Manager at 1-203-436-6654

FDA District:

New England

FDA Comments:

Defibtech®, LLC, began notifying its distributors and customers by letter on February 22, 2007. Defibtech®, LLC, determined the need for this recall after learning of three reports of malfunctions from end users. The company has provided a maintenance procedure that can be used to verify functionality of the device until the software upgrade has been installed, allowing the device to remain in service. A copy of this maintenance procedure is being mailed to customers. See nearby links for more information. Contact your distributor or contact Defibtech®, LLC, at 1-877-453-4507 or 1-203-453-4507.

Defibtech®, LLC, will give customers free software upgrades to address this issue for all affected AEDs. People can install this software upgrade in the field where the unit is located. The software upgrade is expected to be available within the next ten weeks.

Defibtech®, LLC, has distributed approximately 42,000 units worldwide through distributors to end users including: schools, Fire & EMS, businesses, health clubs and hospitality companies. You can identify these products by the words “Lifeline AED®” and “ReviveR AED TM” on the fronts of them.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that, should this particular malfunction occur, use of the affected product may cause serious injury or death if the problem is not corrected.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program. See nearby link to MedWatch.